System for Occluding a Blood Vessel, Especially After Artery Catheterization

ABSTRACT

A system for occluding a blood vessel at a site of puncture of a blood vessel, especially after artery catheterization, comprises an oblong occlusive means ( 13 ) that has a shank ( 14 ) and a compression surface ( 15 ) configured thereon as the end face. The shank comprises a continuous bore ( 17 ) that extends through the compression surface to accommodate at least one guide means ( 11 ) inserted into the blood vessel and is, on the distal end ( 20 ) opposite the compression surface, adapted to be fixed on the patient on the skin when the compression surface is advanced towards the site of puncture ( 2 ).

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a National Phase patent application of InternationalApplication Number PCT/EP2005/004287, filed on Apr. 21, 2005, whichclaims priority of DE 10 2004 022 780.2 filed May 3, 2004.

The invention relates to a system for occluding a blood vessel at a siteof puncture of a blood vessel, especially after artery catheterization.

The endovascular diagnosis and therapy of cardiac and vascular diseasesalmost always necessitates access to the arterial system via theinguinal arteries. After puncture of the artery, a vascular sheath isintroduced, via which the diagnosis or therapy catheters are placed.After the end of the intervention, this sheath is removed and pressureis exerted percutaneously on the site of puncture from the outside inorder to seal it by compression with the help of natural coagulation.

This customary procedure includes, initially, relatively long manualcompression of the tissue containing the site of puncture, followed byseveral hours of compression by means of a bandage. Not only, butprimarily, in adipose patients, with this method, adequate pressurecannot be focused on the site of puncture, such that, occasionally,there is increased bleeding into the perivascular tissue. Thesehematomas are threatening to the patient from several standpoints:

Loss of blood may result in circulatory instability,

The patient requires blood transfusions with the known risk ofinfection,

The hematoma is painful, increases the risk of local infection, and isonly very slowly resorbed by the body,

In the region of the hematoma, resorption causes tissue inflammationwith changes that render further local interventions or operations muchmore difficult, and

Bleeding is not stopped by the hematoma that develops and the site ofpuncture must be sutured in an emergency procedure.

All the above mentioned scenarios necessitate a relatively longmonitoring outlay and are disadvantageous both to the patient andeconomically. A relatively long hospitalization of the patient is notuncommon.

From WO 02/072188, a system is known for hemostasis of an artery thathas a puncture after arterial catheterization. For this, an apparatus isused that has an elongated flexible hollow shaft that can be insertedinto the artery through a catheter introducer. On its forward end, theshank carries an anchor balloon and, axially offset therefrom, avascular sealing balloon. It is operated in that the shaft is pushed viathe catheter introducer far enough into the artery that the anchorballoon is pushed out of the catheter introducer to lie in the artery.After inflation of the anchor balloon, the shaft and the catheterintroducer are retracted until the inflated anchor balloon lies againstthe inside wall of the artery, whereupon the catheter introducer iswithdrawn.

Next, the extravascular balloon is inflated while the anchor balloon isdeflated and the shank retracted far enough that its tip no longer isinside the artery while the site of puncture remains sealed by thevessel sealing balloon thus inflated. After the puncture at the site ofpuncture is sealed by natural coagulation, the vessel sealing balloon islikewise deflated and the entire apparatus is withdrawn from theintervention channel. This apparatus is expensive and its operationrequires a considerable degree of delicate caution.

The object of the invention is, consequently, to provide a system whichreliably enables prevention of protracted bleeding and large hematomasafter the puncture of a vessel, in particular an artery, in a relativelysimple manner.

To accomplish this object, the system according to the invention has thecharacteristics of claim 1.

The new system operates with an oblong occlusive means that has a shankand a compression surface configured thereon as the end face, wherebythe shank comprises a continuous bore that extends through thecompression surface to accommodate at least one guide means insertedinto the blood vessel, and is, on the distal end opposite thecompression surface, adapted to be fixed on the patient on the skin whenthe compression surface is advanced towards the site of puncture.

The oblong occlusive means makes it possible to optimize theextravascular pressure on the site of puncture after the puncture of avessel, in particular an arterial vessel since the compression surfacecan be placed, using the guide means, for example, a Seldinger wire, inposition relative to the site of puncture in the immediate vicinity ofthe outer vessel wall, with the shank protruding into the skin throughthe incision point making it possible to exert locally concentrated,precisely measured pressure on the tissue in the region of the site ofpuncture such that reliable occlusion of the puncture in the vessel wallis obtained. The temporal duration of the pressure action may beselected at will since the shank of the occlusive means can be fixed ina simple manner on the skin level, for instance, by a dressing or abandage. After coagulation of the blood at the site of puncture, theocclusive means can be retracted and removed simply. The occlusion meansitself is economical to produce such that from this standpoint as wellthere is a reduction in the treatment costs associated with acatheterization.

The shank of the occlusive means is preferably designed substantially inthe shape of a cylinder; however, other purpose-appropriatecross-sectional shapes, e.g., oval, may be used. It is also conceivableto design the shank with longitudinal ribs or depressions or with aprofile that yields special flexibility characteristics. It is alsoexpedient for the shaft to have an area with an enlarged cross-sectionalsurface that carries the compression surface. Furthermore, the shankmay, for example, be designed like a piston and have a substantiallysmooth-walled shank portion that connects to the area of enlargeddiameter. Starting from the compression surface formed on the end face,the area of enlarged diameter can transition continuously over thelength of the shank into the smooth-walled shank portion. The size ofthe compression surface is thus independent of the cross-sectional areaof the shank such that the two elements can be selectedpurpose-appropriately. In principle, embodiments are also possible inwhich the compression surface is formed on a shank that has asubstantially equal diameter over its entire length.

The compression surface may be substantially circular in shape; however,it is often advantageous for the compression surface to be oblong inorder to better adapt the pressure area to the course of the vessel andto the possibly elongated site of puncture. Usually, the compressionsurface is designed running substantially perpendicular to thelongitudinal axis of the shank; however, embodiments are alsoconceivable in which the compression surface runs at an angle deviatingfrom 90° oblique to the longitudinal axis of the shank, thus taking intoaccount the fact that the access channel to the vessel usually forms anacute angle with the longitudinal axis of the vessel.

The compression site is usually flat but may also be, dependingprimarily on the region, rounded (convex) or concave or textured.

To enable adaptation to the anatomical characteristics of differentpatients in the vicinity of the site of puncture, the shank can bedesigned variable in its length. For this, the shank may, for instance,be designed telescopically or have two parts connected to each other byscrew threads. It is also conceivable for the shaft to be designed withpredetermined breaking points positioned at intervals relative to eachother in the longitudinal direction of the shank that enable bringingthe shank to a purpose-appropriate length by breaking off a section ofthe shank protruding beyond the skin of the patient when the occlusionmeans is used. Obviously, other designs that enable apurpose-appropriate adjustment of shank length in a simple manner arealso conceivable.

In order to seal the bore passing through the shank to accommodate theguide means during placement of the occlusion means after removal of theguide means, a sealing means may be provided for the bore of the shank,which, is designed, for instance, in the form of a plug. The sealingmeans may have a portion introducible into the bore of the shank thatsubstantially fills the bore over at least a section of its longitudinalextension. Thus, if necessary, it is possible to prevent a column ofcoagulated blood from remaining in the bore. The sealing means may,however, also be in the form of a cap on the shank. In practice, thebore may optionally also be simply sealed by a cotton styptic or thelike.

It may also be expedient for the shank to have, on its distal end, awidening that

is, for instance, designed with a cap-like shape and is attached to theshank as one piece or is removable. In the latter case, the cap-likewidening may simultaneously form the sealing means for the bore in theshank. The widening on the distal shank end yields, in any case, a largesupport area for a dressing fixing the occlusive means in the skin area,perhaps in the form of a bandage, a dressing, or the like.

Finally, embodiments are also conceivable in which the occlusive meanshas a balloon in the vicinity of the compression surface, which isinflatable via a line running through the shank, and it permits thecompression surface to expand after placement of the occlusive means andto generate an additional pressure effect. The balloon may be arranged,in the uninflated state, at least partially, in a recess in the regionof the compression surface and/or in the bore of the shank in order tothus facilitate the introduction of the compression means into theintroduction channel present in the tissue.

Additional advantageous characteristics and embodiments of the systemaccording to the invention for intracorporeal maximization of pressurefor the occlusion of blood vessels, in particular after arterycatheterization, are the subject matter of dependent claims and areobvious from the following description of exemplary embodiments of theobject of the invention.

The drawings depict exemplary embodiments of the object of theinvention. They depict:

FIG. 1 a partial schematic depiction of the arterial blood vessel systemof a patient showing the femoral artery access region for cardiaccatheterization,

FIG. 2 an exposed femoral artery access region of the depiction of FIG.1, showing a puncture site on the ventral side of the Arteria femoraliscommunis,

FIG. 3 through 9

i) in each case, a longitudinal depiction of the thigh at the puncturesite depicted in FIG. 2, showing significant steps in the puncturing ofthe Arteria femoralis communis in connection with a catheterization andthe subsequent occlusion of the puncture site with the vascularocclusion system according to the invention,

FIG. 10 an occlusive means of the vascular occlusion system according tothe invention in a first embodiment in a schematic depiction, greatlyenlarged,

FIG. 11 the occlusive means of FIG. 1 in a top plan view of thecompression surface,

FIG. 12 the occlusive means of a vascular occlusion system according tothe invention in a second embodiment, in a different scale, and apartial cross-sectional depiction corresponding to FIG. 10,

FIG. 13 the occlusive means of FIG. 12 in a top plan view of thecompression surface,

FIG. 14 the occlusive means of a vascular occlusion system according tothe invention in a third embodiment, in a schematic longitudinal sectionsimilar to FIG. 12 and in a corresponding scale,

FIG. 15 the occlusive means of FIG. 13 in a top plan view of thecompression surface,

FIG. 16 the occlusive means of a vascular occlusion system according tothe invention in a fourth embodiment with a shank variable in length, ina schematic longitudinal section similar to FIG. 12 and in acorresponding scale,

FIG. 17 the occlusive means of a vascular occlusion system according tothe invention in a fifth embodiment, in a schematic longitudinal sectionsimilar to FIG. 12, showing a balloon arranged in the region of thecompression surface in the inflated state,

FIG. 18 the occlusive means of FIG. 17 in the top plan view of theinflated balloon, and

FIG. 19 a sealing means for one of the occlusion means of one of FIGS.10 through 18, in a schematic side view.

In order to perform, for instance, a cardiac catheterization in thepatient 1 depicted in FIG. 1, an access into the Arteria femoraliscommunis 3, through which a catheter is advanced to the heart 300, ismade in a thigh of the patient 1 at a site of puncture 2.

The puncture lies, as the exposed site of puncture in FIG. 2 shows,somewhat ventrally in the Arteria femoralis communis 3, which runs nearthe Vena femoralis 4 and is located between the inguinal ligament(ligamentum inguinale) 5 and the Arteria femoralis superficialis 6 andthe Arteria profunda femoris 7.

In the creation of the access to the Arteria femoralis communis 3 andthe introduction of the catheter into this artery, basically, the stepsdepicted schematically in the sectional images of FIGS. 3 through 7 areperformed:

Through the skin 8 of the thigh and the underlying subcutaneous tissue9, the artery wall is punctured at the site of puncture 2 with a hollowneedle 10 (FIG. 3). Then, through the hollow needle (aspiration cannula)10, a guide means in the form of a guide wire or a so-called Seldingerwire 11 is introduced into the artery 3 and advanced in the direction ofthe heart (FIG. 4). After the removal of the hollow needle 10 (FIG. 5),guided by the guide wire 11, a vascular sheath 12 is set in the artery 3(FIG. 6), whereupon the guide wire 11 is pulled out (FIG. 7), such thatthe vascular sheath 12 is free for the introduction (not shown) of adiagnostic or therapy catheter. It should be noted here that basicallythe same procedure is also used for other peripheral vascularinterventions. The catheter can also be placed brachially, for example.Cardiac catheterization is merely one illustrative example.

After finishing the catheterization, the catheter is removed, whereuponthe vascular sheath 12 is removed. After removal of the vascular sheath12, the puncture at the site of puncture 2 in the artery wall must besealed, in order to

prevent bleeding with the complications mentioned in the introduction.In practice, this is usually accomplished in that, as already explained,after removal of the vascular sheath 12, the site of puncture iscompressed by the physician or another trained individual by pressure onthe skin of the thigh for a period of approximately 5 minutes or longer,until natural blood coagulation seals the puncture at the site ofpuncture. This is laborious and time-consuming for the physician or thetrained individual and, moreover, for example, with adipose patienceonly inadequately possible.

This is where the invention starts, which provides a system forintracorporeal pressure maximization or for producing optimal externalpressure for vascular occlusion at the site of puncture after arterycatheterization. The new system works with an oblong occlusive means 13that is placed, as will be explained, in the vicinity of the puncture atthe puncture site 2 in the perivascular tissue. Pressure that compressesthe perivascular tissue in the vicinity of the site of puncture and thusresults in hemostasis is exerted on the occlusive means 13 from theoutside. Through subsequent fixing of the occlusion means 13 at the skinlevel, the compression of the perivascular tissue is maintained for therequired time without this requiring an additional or long-lastingaction of the physician or of the trained individual.

The occlusive means 13 is depicted in various embodiments in FIG. 9through 19. Basically, it has an oblong shank 14, which is usuallycylindrical and smooth walled and which bears on one end face acompression surface 15 which is oriented perpendicular to the shank'slongitudinal axis 16. However,

embodiments are also conceivable in which the compression surface 15 isinclined at an angle deviating from 90° relative to the shank'slongitudinal axis in order to obtain a better adaptation to theanatomical conditions of its use. The shank 14 has a continuous bore 17that runs concentric to the shank's longitudinal axis 16 and opens inthe area of the compression surface 15. In the embodiment according toFIG. 10, 11, the circular shaped compression surface 15 has the samediameter as the cylindrical shank 14. In contrast, in the embodimentaccording to FIG. 12, 13, the compression surface 15 is designed on thebottom of a flange-like region 18 with an enlarged cross-sectionalsurface formed on the shank 14. The flange-like region 18 issubstantially disk shaped and is connected at an angle of 90° to theshank's longitudinal axis 17 to the shank 14, which thus substantiallyassumes the shape of a piston. The region 18 is rounded on its edge atreference number 19. The cylindrical shank 14 is provided in this casein a section 21 connected on the distal end 20 relative to thecompression surface 15 with circumferential ribs 22 that are positionedat axial intervals and form predetermined breaking points. The shank 14can, consequently, be varied in length in a simple manner by breaking atone of these predetermined breaking points.

The embodiment according to FIG. 14,15 is, in principle, similar to thataccording FIG. 12,13 but with the difference that the region 18 with anenlarged cross-sectional surface that carries the compression surface15, transitions at reference number 220 over the length of the shank 14continuously to the connected smooth-walled shank portion. Whereas inthe embodiments explained according to FIG. 10 through 13, thecompression surface 15 is circular, in the embodiment according to FIG.14,15 it is designed oblong, as may be discerned, in particular fromFIG. 15. Through this design of the outline of the compression surface15, the area in which the perivascular tissue is compressed during theuse of the occlusive means 13 is, if necessary, better adapted to thepunctured artery. It should also be noted that with all embodiments ofthe occlusive means 13, the compression surface 15 can be designedcircular, oblong, or with a different outline that proves advantageousfor the respective use.

The compression surface 15 may have, in the region of the opening of thebore 17, a recess at least partially surrounding the opening of thebore, as is depicted with broken lines at reference number 23 in FIG.14,15. This yields a ring-shaped compression surface 15 that results incorresponding ring-shaped pressure distribution in the compression ofthe perivascular tissue.

A cap 24 rounded on the top, which forms, for one thing, a sealing meansfor the bore 17 in the shank 14 and represents, for another thing, awidening on the distal shank end 20 that facilitates the fixing of theocclusion means 13 on the patient, as will be explained in detail, isplaced on the shank 14. The cap 24 may even be connected unremovably tothe shank 14, by being formed thereon, for example, whereby the thencontinuous bore 17 can be sealed by its own plug. The shape of the cap24 is determined by the respective needs and anatomical conditions atthe site of puncture. The shank widening formed thereby may, forexample, also have a more plug-shaped cylindrical design, as depicted inFIG. 9 at 24 a.

The embodiment according to FIG. 16 is substantially similar to thataccording to FIG. 14 but with the difference that the shank 14 has twocoaxial shank sections 14 a, 14 b that are connected to each other by athreaded connection 25 that is covered toward the outside with aprotective sleeve 26 that slides on or is connected to one of the shankparts 14 a, 14 b. The design enables adjustment of the shank length byrotating the shank part 14 a selectively based on the needs of therespective application. In principle, it is also conceivable to omit thethreaded connection 25 and design the two parts 14 a, 14 b to slide ineach other telescopically in order to enable the desired variation inlength of the shank 14.

Finally, the embodiment according to FIG. 17,18 likewise correspondssubstantially to that according to FIG. 14, but here, in the region ofthe in this case circular compression surface 15 a torus-shaped,inflatable balloon 27 that can be inflated via a line 28 running throughthe bore 17 and by introduction of an inflation medium is provided. Inthe uninflated state, the balloon 27 is folded at least partially in therecess 23 provided in the region 18 with the enlarged diameter, whereby,optionally, it may even be partially accommodated in the bore 17. Theballoon 17 [sic] makes it possible to increase the compression pressureexerted on the tissue with the occlusion means 13 already placed in theperivascular tissue and/or to control it precisely since the activecompression surface 15 a now lies on the bottom side of the balloon.Moreover, it is thus possible to enlarge the compression surfacelaterally.

During placement of the occlusion means in the tissue, the balloon 27 isdeflated such that it does not interfere with the placement of theocclusion means.

Finally, FIG. 19 shows a sealing means designed as a plug 29 for thebore 17 in the shank 14. The plug 29 has a knob-like handle 30 and acylindrical plug part 31 connected thereto that can be pressed sealinglyinto the bore 17 of the shank 14. The plug part 31 is usually just longenough that a secure hold in the bore 17 is ensured. However,embodiments are also conceivable in which, as shown in FIG. 19, itextends over the entire length or a substantial part of the length ofthe bore 17, in order to fill it completely and thus to prevent thedevelopment of a thrombus in the bore 17.

The function of the system according to the invention is clear from thefollowing description of the handling of the occlusive means 13:

Referring to FIG. 7, after completion of the intervention, theintervention catheter is removed from the vascular sheath 12.

Starting from the state according to FIG. 7, the guide means in the formof an introduction wire or a Seldinger layer 11 is advanced again intothe artery 3 via the vascular sheath 12, whereby the situation accordingto FIG. 6 is restored.

Now, the vascular sheath 12 is removed and the occlusive means 13 isadvanced through the existing access channel to the site of puncture 2in the vicinity of the site of puncture. At this time, the perivasculartissue 9 in the region of the site

of puncture 12 is locally compressed by the compression surface 15, asshown in FIG. 8 at 32. Now, the situation according to FIG. 8 isobtained, in which the shank 14 protrudes beyond the patient's skin 8 atthe incision site. If necessary, a dilator may be used to facilitate theplacement of the occlusive means 13.

The introduction wire or Seldinger wire 11 is now removed and theexternal pressure on the site of puncture 2 is maximized with theocclusive means 13 to minimize the escape of blood. At this time oralready in a preparatory step, the length of the shank 14 of theocclusive means 13 is adapted to the respective anatomical conditions,i.e., substantially, the thickness of the perivascular tissue and of thesubcutaneous tissue 9 in the region of the site of puncture 2, if anocclusive means 13 with an appropriate fixed shank length was not usedfrom the outset.

Moreover, if necessary, the bore 17 on the distal shank end 20 is sealedeither by means of the plug 29 (FIG. 19) or a cap 24,24 a; and theocclusive means 13 is fixed at skin level by means of a bandage shown inFIG. 1,9 at 33 or a corresponding dressing. The widening on the shankend formed by the cap 24 or the knob 30 (FIG. 19) enables a large-areasupport of the occlusive means 13 on the dressing 33, whereby itsimultaneously forms a support on the surface of the skin. The occlusivemeans 13 is thus further stabilized with regard to its position.

With the use of the occlusive means 13 according to FIG. 17, 18, afterplacement of the occlusive means 13, the balloon 27 is inflated, which,as already mentioned, enables enlarging the compression surface andincreasing and/or delicately controlling the compression pressurewithout having to change the position of the occlusive means 13 itself.

The balloon 27 may also be introduced as a separate part like a ballooncatheter through the bore 17 in the shank 14 and placed in front of thecompression surface 15.

As already mentioned in the introduction, the system according to theinvention is suitable for all vascular interventions in which aperipheral vascular access is made. The cardiac catheterization ismerely used to illustrate the basic mode of action of the new system, asalready has been mentioned.

The occlusive means 13 is, as a rule, manufactured from a biocompatibleand medically approved plastic. Its dimensions are determined accordingto the requirements and the anatomical conditions of the respectiveapplication. As a nonrestrictive example, it is indicated here that thediameter of the bore 17 is preferably between 0.9 and 1.5 mm, dependingon the diameter of the guide wire 11, and the diameter of thecompression surface 15 is preferably within a range from (4) to 6 (8) to9 mm. These dimensions apply with the use of a vascular sheath with theFrench size 5 to 11 (1.65 mm diameter to 3.7 mm diameter). The length ofthe shank 14 is preferably between 3 and 7 cm, but basically depends, asalready mentioned, on the anatomical relationships of the patient in thearea of the site of puncture.

1. System for occluding a blood vessel at a site of puncture of a bloodvessel, especially after artery catheterization, comprises an oblongocclusive means (13) that has a shank (14) and a compression surface(15) configured thereon as the end face, whereby the shank comprises acontinuous bore (17) that extends through the compression surface toaccommodate at least one guide means (11) inserted into the blood vesseland is, on the distal end (20) opposite the compression surface, adaptedto be fixed on the patient on the skin when the compression surface isadvanced towards the site of puncture (2).
 2. System according to claim1, characterized in that the shank (14) of the occlusive means isdesigned with a substantially cylindrical shape.
 3. System according toclaim 1, characterized in that the shank (14) has a region (18) with anenlarged cross-sectional surface that carries the compression surface(15).
 4. System according to claim 3, characterized in that the shank(14) is designed with a piston-like shape and has a substantiallysmooth-walled shank portion that connects to the region (18) with theenlarged diameter.
 5. System according to claim 4, characterized in thatthe region (18) with the enlarged diameter, starting from thecompression surface (15) configured on its end face transitionscontinuously over the length (220) of the shank into the smooth-walledshank portion.
 6. System according to claim 1, characterized in that thecompression surface (15) is substantially circular in shape.
 7. Systemaccording to claim 1, characterized in that the compression surface (15)is oblong.
 8. System according to one of the preceding claims claim 1,characterized in that the compression surface (15) runs substantially ata right angle to the longitudinal axis (16) of the shank (14).
 9. Systemaccording to claim 1, characterized in that the compression surface (15)runs oblique to the longitudinal axis (16) of the shank at an angledeviating from 90°.
 10. System according to claim 1, characterized inthat the compression surface (15) has a recess (23) at least partiallysurrounding the opening of the bore (17).
 11. System according to claim1, characterized in that the shank (14) is designed variable in itslength.
 12. System according to claim 11, characterized in that theshank (14) is designed telescopically.
 13. System according to claim 11,characterized in that the shank (14) has at least two parts (14 a, 14 b)connected to each other by screw threads (25).
 14. System according toclaim 11, characterized in that the shank (14) has predeterminedbreaking points (22) positioned at intervals relative to each other inthe longitudinal direction of the shank.
 15. System according to claim1, characterized in that the shank has a widening on its distal end(20).
 16. System according to claim 15, characterized in that thewidening is designed with a cap-like shape (24).
 17. System according toclaim 15 or 16, characterized in that the widening is releasablyconnected to the shank.
 18. System according to claim 1, characterizedin that it has a sealing means (29) for the bore (17) of the shank (14).19. System according to claim 18, characterized in that the sealingmeans is (24,29) adapted for attachment on the distal end of the shank(20).
 20. System according to claim 18, characterized in that thesealing means has a part (31) insertable into the bore (17) of the shank(14), that substantially fills the bore over at least a section of itslongitudinal extension.
 21. System according to claim 1, characterizedin that the occlusive means (13) has a balloon (27) in the region of thecompression surface that is inflatable via a line (28) running throughthe shank.
 22. System according to claim 21, characterized in that theballoon (27), in the uninflated state, is arranged at least partially ina recess (23) in the region of the compression surface (15) and/or inthe bore (17) of the shank (14).
 23. System according to claim 21,characterized in that the balloon (27) is designed to be introducibleinto the occlusive means through the bore (17) of the shank (14).